MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ANCHORAGE PLATING SYSTEM; IMPLANT

Catalog Number UNK_SEL

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Wound Dehiscence (1154); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

This pi is for the first surgical intervention for wound management.In the journal of the american podiatric medical association september 2016 volume 106, a poster abstract reports the following: "cast study: a (b)(6) female presented with a painful pes planovalgus deformity.Using titanium alloy hardware consisting of the stryker anchorage plating system and 7.0mm stryker headless compression screws.A medial displacement calcaneal osteotomy and a first metatarsal-cuneiform arthrodesis was performed.[three weeks post operatively] there was still erythema [reddening of the skin] present not typical with this post-operative course.By the fourth post-operative week, the first metatarsal-cuneiform arthrodesis incision had dehisced with hardware exposed and the patient began to develop hives on her back.She was admitted to the hospital for aggressive wound management and surgical exploration.The patient underwent a second procedure for surgical debridement and delayed primary closure.Ten days after the debridement and closure revealed a larger erythematous reaction at both surgical sites.She was referred to an allergist.Positive results were detected for titanium and vanadium allergy.Throughout the course, she underwent multiple procedures for debridement and removal of all internal fixation.".

• Brand Name: UNKNOWN ANCHORAGE PLATING SYSTEM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7930023
• MDR Text Key: 122502740
• Report Number: 0008031020-2018-00758
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR